Effect of intermittent normobaric hypoxia-hyperoxia in patients with hert failure with reduced ejection fraction

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033439

Enrollment

Registered

2024-09-11

Start date

2024-09-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50

Interventions

Group 1: Intervention group: Exposure to intermittent normobaric hypoxia-hyperoxia, 3 sessions (30-60 min) per week for 10 weeks

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: - Symptoms of heart failure / dyspnea (NYHA II-III) - Clinically stable under optimal drug therapy as recommended by the ESC-HF guidelines (> 4 weeks)

Exclusion criteria

Exclusion criteria: - Severe or poorly controlled comorbidities: (e.g. COPD (GOLD stage IV) or other debilitating lung diseases, renal insufficiency stage = 4 (eGFR 8 %), anemia (Hb 1,800 m) in the last 3 months - Increased blood loss (> 200 ml) in the last 3 months or therapy with erythropoietin or blood administration in the last 6 months - Participation in additional interventions/ training programs during the intervention period (e.g. physical training, diets, drug trials) - Participation in other clinical studies

Design outcomes

Primary

Measure	Time frame
This pilot study follows an exploratory approach. Therefore, no primary outcome parameter is defined.	—

Secondary

Measure	Time frame
(i) Cardiopulmonary fitness and functional capacity measured via symptom limited cardiopulmonary exercise test (i.e., peak oxygen consumption, V?’E/V?CO2-Slope, end-tidal CO2 pressure at rest, oxygen uptake efficiency slope, heart rate recovery at 1 min, and maximal as well as submaximal (at the first ventilatory threshold) power) and six-minute walk test (i.e., distance), respectively. (ii) Muscle structure, metabolism, oxygen homeostasis, inflammatory, and oxidative status via muscle biopsy. (iii) Muscle function via isokinetic measurements (i.e., peak torque at 5 x 60°/s (strength) and performance fatigue index at 15 x 180°/s (endurance)). (iv) Haemodynamics (i.e., blood pressure and endothelial function via flow mediated dilatation test) as well as cardiac function and structure (i.e., diastolic (E/A, E/é, é) and systolic (left ventricular ejection fraction) function as well as left ventricular volume index, strain, and emptying fraction) via echocardiography. (v) Trait fatigue (via Fatigue Severity Scale, Fatigue Scale for Motor and Cognitive Function). (vi) Quality of life (via Minnesota Living with Heart Failure Questionnaire, Depression, Anxiety, and Stress Scale-21, Pittsburgh Sleep Quality Index). (vii) Blood parameters (i.e., B-type natriuretic peptide (BNP), N-terminal pro BNP (NT-pro BNP), tumor-necrosis factor a (TNF-a), C-reactive protein (CRP), interleukin 6 (IL-6)). (viii) Acute perceptual responses associated to the treatment (via ratings of perceived exertion, difficulty breathing, affective valence, arousal, symptomes of acute moutain sickness).	—

Measure

Time frame

(i) Cardiopulmonary fitness and functional capacity measured via symptom limited cardiopulmonary exercise test (i.e., peak oxygen consumption, V?’E/V?CO2-Slope, end-tidal CO2 pressure at rest, oxygen uptake efficiency slope, heart rate recovery at 1 min, and maximal as well as submaximal (at the first ventilatory threshold) power) and six-minute walk test (i.e., distance), respectively. (ii) Muscle structure, metabolism, oxygen homeostasis, inflammatory, and oxidative status via muscle biopsy. (iii) Muscle function via isokinetic measurements (i.e., peak torque at 5 x 60°/s (strength) and performance fatigue index at 15 x 180°/s (endurance)). (iv) Haemodynamics (i.e., blood pressure and endothelial function via flow mediated dilatation test) as well as cardiac function and structure (i.e., diastolic (E/A, E/é, é) and systolic (left ventricular ejection fraction) function as well as left ventricular volume index, strain, and emptying fraction) via echocardiography. (v) Trait fatigue (via Fatigue Severity Scale, Fatigue Scale for Motor and Cognitive Function). (vi) Quality of life (via Minnesota Living with Heart Failure Questionnaire, Depression, Anxiety, and Stress Scale-21, Pittsburgh Sleep Quality Index). (vii) Blood parameters (i.e., B-type natriuretic peptide (BNP), N-terminal pro BNP (NT-pro BNP), tumor-necrosis factor a (TNF-a), C-reactive protein (CRP), interleukin 6 (IL-6)). (viii) Acute perceptual responses associated to the treatment (via ratings of perceived exertion, difficulty breathing, affective valence, arousal, symptomes of acute moutain sickness).

—

Countries

Germany

Contacts

Public ContactTarek Bekfani

Universitätsklinik für Kardiologie und Angiologie

tarek.bekfani@med.ovgu.de+49-391-67-01

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026