Efficacy of Passive Leg Movement on Heart Failure with Preserved Ejection Fraction During the Period of Hospitalization: A Randomized Controlled Clinical Study

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ICR-15005995
• Date of registration: 2015-02-12
• Prospective Registration: Yes
• Primary sponsor: The Second Affiliated Hospital of Nanchang University
• Public title: Efficacy of Passive Leg Movement on Heart Failure with Preserved Ejection Fraction During the Period of Hospitalization: A Randomized Controlled Clinical Study
• Scientific title: Efficacy of Passive Leg Movement on Heart Failure with Preserved Ejection Fraction During the Period of Hospitalization: A Randomized Controlled Clinical Study
• Date of first enrolment: 2015-03-01
• Target sample size: Experimental group:70;Control group:70;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10458
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Dong Yifei

• Name: Dong Yifei
• Affiliation: The Second Affiliated Hospital of Nanchang University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Stable symptomatic heart failure with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology: Paulus et al., 2007);
1.1. New York Heart Association (NYHA) II-III;
1.2. Left ventricular ejection fraction (LVEF) >=50%;
1.3. Ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E')(E/E') >=15;
1.4. 8 <= E/E' <15 and at the same time meet one of the following requirements: (1) NT-proBNP >220 ng/L or BNP >200 ng/L; (2) LVMI >=122g/m2(female) or 149g/m2(male);
2. Age older than 18 years;
3. Written informed consent of the patient.
Exclusion criteria: 1. Non-cardiac causes for heart failure like symptoms:
1.1. Chronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages >=II;
1.2. Significant renal dysfunction estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2;
1.3. Significant peripheral artery disease (Fontaine >=IIb);
1.4. Musculoskeletal disease that contribute to reduced exercise performance;
1.5. Specific cardiomyopathy and pericardial disease (e.g. amyloidosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericardial disease etc.);
1.6. Haemodynamically significant valvular disorders;
2. Lower limb vein thrombus or lower limb skin ulcer;
3. Significant coronary artery disease (CAD) [current angina pectoris, Canadian Cardiovascular Society (CCS) >=II or positive stress test, myocardial infarction or coronary artery bypass graft within the last 3 months);
4. Any inability or contraindication to participate in an exercise program (e.g. physiological, mental) or supply essential information (e.g. questionnaire);
5. Ineffective control of resting blood pressure (BP >=140/90mmHg or BP >=160/100mmHg with >=3 antihypertensive drugs) or of resting heart rate (HR >=100bpm);
6. Concomitant participation in other interventional clinical trials.

Age minimum: 18
Age maximum: 85
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure with Preserved Ejection Fraction

Intervention(s)

Experimental group:Passive Leg Movement;Control group:Without Passive Leg Movement;

Primary Outcome(s)

6 minutes walk test;

Secondary Outcome(s)

Minnesota Living With Heart Failure Questionnaire (quality of life);Cardiac diastolic function;Pressure of pulmonary circulation;Endothelial function;NT-pro BNP;Exhaled nitric oxide level;Length of hospital stay;

Source(s) of Monetary Support

National Natural Science Foundation of China