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A nutrition and lifestyle intervention in patients with PuLmonary Arterial Hypertension: effect on quality of life

Recruiting
Conditions
high blood pressure in the pulmonary arteriole
Pumonary Arterial Hypertension
10019280
10037454
Registration Number
NL-OMON48646
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
70
Inclusion Criteria

Diagnoses of idiopathic PAH, hereditary PAH or drug related PAH
Age between 18 and 80
NYHA II or III and stable for at least three months, measured with 6MWT <10%
differnce
Self-sufficient and/or compliance from partner and/or family
Creatinine > 30 ml/min
Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria

Pregnant subjects
Fat percentage < 10% > 55%
One or more of the following comorbidities: diabetes mellitus type one or two,
clinical relevant hypothyroid
Known history of noncompliance considering therapies

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To explore the effect of a nutrition and lifestyle intervention for<br /><br>PAH-patients on quality of life. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Perform a systematic analyses of nutritional status. Is nutritional status<br /><br>associated with clinical worsening or RV function in PAH?<br /><br>- Determine the effect of nutritional education alone, and the additional<br /><br>effect of a nutritional intervention in PAH.<br /><br>- Determine which nutritional intervention is most effective. Which diet is<br /><br>associated with the largest improvement in quality of life and best compliance<br /><br>in PAH?</p><br>
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