Abstract
Impaired exercise capacity is the core symptom of heart failure with preserved ejection fraction (HFpEF). We assessed effects of exercise training and Crataegus extract WS 1442 in HFpEF and aimed to identify mechanisms of action in an exploratory trial (German Clinical Trials Register DRKS00000259). 140 sedentary HFpEF NYHA II patients on standard treatment received eight weeks of aerobic endurance training and half were randomized to WS 1442 900 mg/day. Symptoms, 2 km walking time (T2km), parameters of exercise tolerance, cardiac and vascular function, muscular efficiency and skeletal muscular haemoglobin oxygen saturation (SO2) measured during a treadmill protocol were captured at baseline and after eight weeks. Adverse events were recorded during the trial. Mechanisms of action were explored by correlation and path analyses of changes. Symptoms and exercise capacity improved with training, but correlations between improvements were low and path models were rejected. SO2 increased, decreased or undulated with increasing exercise intensity in individual patients and was not altered by training. WS 1442 improved T2km (-12.7% vs. -8.4%, p = 0.019), tended to improve symptoms and to pronounce SO2-decrease with increasing exercise, an indicator of oxygen utilisation. Endurance training and WS 1442 were safe and well tolerated in combination with standard drug treatment.
Highlights
At least half of patients with chronic heart failure suffer from diastolic dysfunction with preserved left ventricular ejection fraction (HFpEF) [1]
For 7 patients (5 training and WS 1442, 2 training only) no efficacy data were available after randomization, 133 patients were analysed for efficacy
Anecdotal reports from the training groups in our study indicated that social interaction, psychological factors and getting used to physical activity are important moderators of symptomatic improvement
Summary
At least half of patients with chronic heart failure suffer from diastolic dysfunction with preserved left ventricular ejection fraction (HFpEF) [1]. These patients are elderly women with a longstanding history of arterial hypertension [1]. Crataegus extract WS 1442 has been demonstrated to improve symptoms and exercise tolerance in patients with heart failure, New York Heart Association (NYHA) stage II to III [9, 10], but no specific trials in patients with HFpEF have been conducted. The extract activates endothelial and red blood cell NO-synthase [12,13,14], increases endothelial NO-release and improves endothelium-dependent arterial function in animal models of aging and hypertension [15, 16]. The vascular effects are strongly related to the high content of oligomeric procyanidins in the extract [13]
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