None of the spironolactone trials in heart failure (HF) assessed the blood pressure (BP) responses to exercise, while conflicting results were reported for exercise capacity. In the HOMAGE trial, 527 patients at increased HF risk were randomized to usual treatment with or without spironolactone (25-50 mg/day). The current substudy included 113 controls and 114 patients assigned spironolactone, who all completed the incremental shuttle walk test at baseline and months 1 and 9. Quality of life (QoL) was assessed by EQ5D questionnaire. Between-group differences (spironolactone minus control [Δs]) were analyzed by repeated measures ANOVA with adjustment for baseline and, if appropriate, additionally for sex, age and body mass index. Δs in the pre-exercise systolic/diastolic BP were -8.00 mm Hg (95% CI, -11.6 to -4.43)/-0.85 mm Hg (-2.96 to 1.26) at month 1 and -9.58 mm Hg (-14.0 to -5.19)/-3.84 mm Hg (-6.22 to -1.47) at month 9. Δs in the post-exercise systolic/diastolic BP were -8.08 mm Hg (-14.2 to -2.01)/-2.07 mm Hg (-5.79 to 1.65) and -13.3 mm Hg (-19.9 to -6.75)/-4.62 mm Hg (-8.07 to -1.17), respectively. For completed shuttles, Δs at months 1 and 9 were 2.15 (-0.10 to 4.40) and 2.49 (-0.79 to 5.67), respectively. Δs in QoL were not significant. The correlations between the exercise-induced BP increases and the number of completed shuttles were similar in both groups. In conclusion, in patients at increased risk of developing HF, spironolactone reduced the pre- and post-exercise BP, but did not improve exercise capacity or QoL.

BACKGROUND: Branch pulmonary artery (PA) stenosis is one of the most common indications for percutaneous interventions in patients with transposition of the great arteries (TGA), tetralogy of Fallot (ToF), and truncus arteriosus (TA). However, the effects of percutaneous branch PA interventions on exercise capacity remains largely unknown. In addition, there is no consensus about the optimal timing of the intervention for asymptomatic patients according to international guidelines. This trial aims to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with TGA, ToF, and TA. In addition, it aims to assess the effects on RV function and to define early markers for RV adaptation and RV dysfunction to improve timing of these interventions.
METHODS: This is a randomized multicenter interventional trial. TGA, ToF, and TA patients ≥ 8 years with a class IIa indication for percutaneous branch PA intervention according to international guidelines are eligible to participate. Patients will be randomized into the intervention group or the control group (conservative management for 6 months). All patients will undergo transthoracic echocardiography, cardiac magnetic resonance (CMR) imaging, and cardiopulmonary exercise testing at baseline, 6 months, and 2-4 years follow-up. Quality of life (QoL) questionnaires will be obtained at baseline, 2 weeks post intervention or a similar range for the control group, and 6 months follow-up. The primary outcome is exercise capacity expressed as maximum oxygen uptake (peak VO2 as percentage of predicted). A total of 56 patients (intervention group n = 28, control group n = 28) is required to demonstrate a 14% increase in maximum oxygen uptake (peak VO2 as percentage of predicted) in the interventional group compared to the control group (power 80%, overall type 1 error controlled at 5%). Secondary outcomes include various parameters for RV systolic function, RV functionality, RV remodeling, procedural success, complications, lung perfusion, and QoL.
CONCLUSIONS: This trial will investigate the effects of percutaneous branch PA interventions on exercise capacity in patients with TGA, ToF, and TA and will identify early markers for RV adaptation and RV dysfunction to improve timing of the interventions.
BACKGROUND: ClinicalTrials.gov NCT05809310. Registered on March 15, 2023.

BACKGROUND: Considering the limitations in activities of daily living (ADL) and the impact of improvements in patients with heart failure (HF), appropriate assessment of upper extremity functional capacity and ADL is important.
OBJECTIVE: To evaluate upper extremity functional capacity and ADL in patients with HF and compare them with healthy controls.
METHODS: This study included 30 HF patients and healthy controls. Upper extremity functional capacity was assessed with the 6-Minute Pegboard Ring Test (6PBRT), ADL by the Londrina protocol, exercise capacity by 6-Minute Walk Test (6MWT), peripheral muscle strength by hand dynamometer, and dyspnea by Modified Medical Research Council Scale (MMRC). For performance tests, pre-test (resting) and post-test (after performance) values ​​were also measured.
RESULTS: Patients with HF with ejection fraction ≤50 % and controls were similar in terms of age (52.63±6.2 and 50.03±6.5 years, respectively) and gender (25 females for each group) (p > 0.05). Patients showed a statistically significant increase in total test time in the Londrina protocol and fewer rings moved in 6PBRT (p < 0.0001). The post-test dyspnea (p = 0.03) and pre-test arm fatigue (p < 0.0001) were observed to be higher in patients in the Londrina protocol. There was a statistically significant group by time interaction in the patients\' pre- and post-test lower heart rate (F= 4.80, p = 0.03), post-test dyspnea (p < 0.0001), and post-test arm fatigue (p = 0.005) were observed to be higher in patients in 6PBRT.
CONCLUSIONS: The evidence showed a decrease in upper extremity functional capacity in patients with HF. Patients required more time to perform their ADLs compared with healthy controls.

OBJECTIVE: Evidence is lacking that correcting iron deficiency (ID) has clinically important benefits for patients with heart failure with preserved ejection fraction (HFpEF).
METHODS: FAIR-HFpEF was a multicentre, randomized, double-blind trial designed to compare intravenous ferric carboxymaltose (FCM) with placebo (saline) in 200 patients with symptomatic HFpEF and ID (serum ferritin < 100 ng/mL or ferritin 100-299 ng/mL with transferrin saturation < 20%). The primary endpoint was change in 6-min walking test distance (6MWTD) from baseline to week 24. Secondary endpoints included changes in New York Heart Association class, patient global assessment, and health-related quality of life (QoL).
RESULTS: The trial was stopped because of slow recruitment after 39 patients had been included (median age 80 years, 62% women). The change in 6MWTD from baseline to week 24 was greater for those assigned to FCM compared to placebo [least square mean difference 49 m, 95% confidence interval (CI) 5-93; P = .029]. Changes in secondary endpoints were not significantly different between groups. The total number of adverse events (76 vs. 114) and serious adverse events (5 vs. 19; rate ratio 0.27, 95% CI 0.07-0.96; P = .043) was lower with FCM than placebo.
CONCLUSIONS: In patients with HFpEF and markers of ID, intravenous FCM improved 6MWTD and was associated with fewer serious adverse events. However, the trial lacked sufficient power to identify or refute effects on symptoms or QoL. The potential benefits of intravenous iron in HFpEF with ID should be investigated further in a larger cohort.

UNASSIGNED: Exercise capacity reflects the cardiovascular risk after myocardial infarction (MI). The study aims to evaluate the impact of sleep-disordered breathing (SDB) on exercise capacity after MI.
UNASSIGNED: Consecutive patients referring to outpatient cardiac rehabilitation up to 28 days after MI and participating in the Polish Managed Care after Acute Myocardial Infarction (MC-AMI) program were included. On admission, we assessed the presence and the severity of SDB using the home sleep apnea test (HSAT), patients\' maximum exercise capacity on a treadmill exercise stress test (EST), and a 6-minute walk test (6MWT), as well as the effect of SDB on the results obtained. In the multivariate analysis, we verified the strength of the observed associations concerning age, anthropometric parameters, and left ventricular ejection fraction (LVEF).
UNASSIGNED: A total of 254 patients aged 60.00 (interquartile range 51.00-67.00), including 39 (15.4%) women, with technically adequate HSAT, constituted the study group. Mild SDB was found in 82 (32.3%), moderate in 54 (21.3%), and severe in 51 (20.1%) patients. Among those diagnosed with SDB, obstructive sleep apnea (OSA) was dominant in 167 (89.8%). With the worsening of SDB, the distance in 6MWT and the maximum physical exertion achieved in EST, expressed in metabolic equivalents (METs) and maximal heart rate (MHR), decreased. The linear regression analysis confirmed the following: (1) inversely proportional relationship between the respiratory event index and METs, MHR, and 6MWT distance (p = 0.005, p = 0.008, and p = 0.004), and the maximum apnea duration and MET and 6MWT distance (p = 0.042 and p = 0.002); and (2) directly proportional relationship between mean arterial oxygen saturation ( SpO 2 ) during sleep and MET, MHR, and 6MWT distance (p = 0.019, p = 0.006, and p = 0.013), and minimum SpO 2 and MET and MHR (p = 0.040 and p < 0.001). However, the independent risk factors for impaired exercise capacity, determined using multivariable regression analysis, were age, female sex, higher body mass index (BMI), and decreased LVEF, but not SDB parameters.
UNASSIGNED: SDB negatively impacts exercise capacity after MI. However, the strength of this association may be less pronounced due to the interaction of risk factors common for SDB and impaired exercise capacity, e.g., sex, age, BMI, and LVEF.

UNASSIGNED: To assess the clinical effectiveness of Yangxinshi (YXS) tablets on exercise capacity and symptoms of anxiety and depression in patients with coronary heart disease (CHD).
UNASSIGNED: A randomized, double-blind, placebo-controlled, multicenter clinical trial was performed to assess the effects of YXS tablets on exercise capacity and quality of life in patients with CHD. A total of 82 patients were included in this trial. Compared with the placebo group, the YXS group showed significant improvement in peak VO 2 (0.22 L/min vs 0.01 L/min; difference 0.1, 95% confidence interval (CI) 0.04-0.16, p = 0.000), peak Mets (0.58 vs 0.09; difference 0.3, 95% CI 0.12-0.47, p = 0.005), anaerobic threshold (AT) VO 2 (0.23 L/min vs 0.04 L/min; difference 0.12, 95% CI 0.07-0.18, p = 0.000), AT Mets (0.62 vs 0.16; difference 0.35, 95% CI 0.2-0.5, p = 0.001), and 6 minutes walking test (6MWT) (50.05 m vs 11.91 m; difference 29.92, 95% CI 18.78-41.07, p = 0.000). There were no differences in Hamilton anxiety rating scale (HAM-A score (1.97 vs 2.07; difference 2.03, 95% CI 0.99-3.06, p = 0.926) and Hamilton depression rating scale (HAM-D) score (1.06 vs 1.7; difference1.42, 95% CI 0.24-2.6, p = 0.592).
UNASSIGNED: In patients with CHD, YXS tablets, compared with placebo, could improve exercise capacity, without beneficial effects on anxiety and depression symptoms.

BACKGROUND: Pulmonary arterial hypertension (PAH)-specific therapies are generally ineffective in patients with pulmonary hypertension associated with lung disease (PH-LD). The aim of this preliminary study was to evaluate the potential efficacy of selexipag, titrated according to individual tolerance, in patients with PH-LD.
METHODS: Consecutive patients diagnosed with PH-LD between October 2016 and March 2019, who received selexipag treatment, were retrospectively evaluated. Specific parameters, including changes in hemodynamic parameters, 6-min walk distance (6MWD), and partial pressure of atrial oxygen/fraction of inspiratory oxygen (PaO2/FiO2) were evaluated. Patients whose 6MWD improved ≥20 m were defined as responders.
RESULTS: Eight patients with PH-LD were included, comprising four with chronic obstructive pulmonary disease (COPD), two with interstitial lung disease (ILD) related to rheumatoid arthritis, one with ILD related to systemic sclerosis, and one with pulmonary Langerhans cell histiocytosis. No statistically significant improvements in hemodynamic parameters and 6MWD were noted following selexipag treatment. However, four patients showed improvements in 6MWD ≥20 m at follow-up and were considered responders. They had a higher body mass index (BMI) and lower PaO2/FiO2 at baseline than non-responders (p = 0.02 and p = 0.04, respectively). No Grade 3 or 4 adverse events were observed.
CONCLUSIONS: Selexipag was effective in half of the PH-LD cases, emphasizing higher BMI and lower PaO2/FiO2 as possible indicators for favorable response. Since selexipag starting at a low dose with subsequent titration may reduce the risk of early adverse events, it can be considered a treatment option for PH-LD. Further large-scale studies are warranted to confirm these findings.

OBJECTIVE: The ability to be physically active is pivotal to the quality of life in elderly patients. This study aims to describe the association between exercise capacity and health-related quality of life (HRQoL), anxiety, and depression following an exercise-based cardiac rehabilitation (CR) program in elderly cardiac patients.
METHODS: Patients aged ≥65 years with acute and chronic coronary syndrome or heart valve surgery were consecutively included from 8 CR centers in 7 European countries. Exercise capacity (VO2peak(ml/kg/min)) was assessed with a cardiopulmonary exercise test (97%) or a six-minute walk test. Outcome variables included HRQoL (SF-36 physical and mental component scores (PCS and MCS)), anxiety (GAD-7), and depression (PHQ-9). Mixed models were used to address the association between baseline and the development in VO2peak, and outcome variables stratified on sex, and adjusted for baseline values, age, and CR center.
RESULTS: A total of 1,633 patients were included (T0), 1,523 (93%) completed end-of-CR assessment (T1), and 1,457 (89%) 1-year follow-up (T2). Women had higher % of predicted VO2peak, but poorer scores in HRQoL, anxiety and depression at all time-points. All scores improved in both sexes at follow-up. We found significant associations between VO2peak at baseline as well as development in VO2peak and all outcome variables at T1 and T2 in men (all p < 0.001). In women, VO2peak was only associated with PCS scores (p < 0.001).
CONCLUSIONS: Improvements in exercise capacity was strongly associated with improvements in HRQoL and mental health, however with stronger associations in men. The results highlight the importance of physical fitness for HRQol and mental health. The findings from this study might be useful to better target individual CR programs.
This study explores the association between exercise capacity and the well-being of elderly cardiac patients participating in a cardiac rehabilitation program, focusing on health-related quality of life (HRQoL), anxiety, and depression. Key Findings:Women, despite having higher percentages of predicted exercise capacity, consistently reported poorer HRQoL, anxiety, and depression scores compared to men at all assessed time points.Improvements in exercise capacity were strongly associated with positive changes in HRQoL and mental health, with these associations being more pronounced in men.

BACKGROUND: Due to their relationship with clinical progression, follow-up of exercise capacity and muscle strength is important for optimal disease management in patients who have undergone the Fontan procedure. We aimed to retrospectively analyze exercise capacity and muscle strength trajectory over approximately 2 years.
METHODS: Exercise capacity was assessed using an exercise stress test with the modified Bruce protocol on a treadmill, hand grip and knee extensor strength using a hand dynamometer, and body composition using a bioelectrical impedance device. Exercise capacity, muscle strength, and body composition follow-up data recorded between 2020 and 2022 were compared.
RESULTS: Fifteen patients [median age from 17 (first assessment) to 18 years (last assessment), 5 females)] with a 20-month median follow-up time were analyzed retrospectively. There was an increase in weight, height, body mass index, and body fat weight (p<0.05). There was a tendency for increased handgrip strength (%) (p=0.069), but no significant difference was observed in the knee extensor strength of patients during the follow-up period (p>0.05). The changes in heart rate (HR) and oxygen saturation were higher in the last test than in the first test (p<0.05). Maximum HR (HRmax), % predicted HRmax and HR reserve recorded during the test and HR 1 minute after the test were similar between the first and last tests (p>0.05).
CONCLUSIONS: After 20 months of follow-up, exercise capacity and muscle strength did not decline; instead, the body mass index and fat weight increased. Patients who have undergone the Fontan procedure may not be experiencing a decline in exercise capacity and muscle strength over relatively short time periods during childhood, adolescence, and early adulthood.

OBJECTIVE: Sacubitril/valsartan treatment reduces mortality and hospitalizations in heart failure with reduced ejection fraction but has limited application in hypertrophic cardiomyopathy (HCM). The aim of this study was to evaluate the effect of sacubitril/valsartan on peak oxygen consumption (VO2) in patients with non-obstructive HCM.
RESULTS: This is a phase II, randomized, open-label multicentre study that enrolled adult patients with symptomatic non-obstructive HCM (New York Heart Association class I-III) who were randomly assigned (2:1) to receive sacubitril/valsartan (target dose 97/103 mg) or control for 16 weeks. The primary endpoint was a change in peak VO2. Secondary endpoints included echocardiographic measures of cardiac structure and function, natriuretic peptides and other cardiac biomarkers, and Minnesota Living with Heart Failure quality of life. Between May 2018 and October 2021, 354 patients were screened for eligibility, 115 patients (mean age 58 years, 37% female) met the study inclusion criteria and were randomly assigned to sacubitril/valsartan (n = 79) or control (n = 36). At 16 weeks, there was no significant change in peak VO2 from baseline in the sacubitril/valsartan (15.3 [4.3] vs. 15.9 [4.3] ml/kg/min, p = 0.13) or control group (p = 0.47). No clinically significant changes were found in blood pressure, cardiac structure and function, plasma biomarkers, or quality of life.
CONCLUSIONS: In patients with HCM, a 16-week treatment with sacubitril/valsartan was well tolerated but had no effect on exercise capacity, cardiac structure, or function.