Exercise-induced Pulmonary Hypertension in Patients With Sickle-cell Anemia

Pulmonary Hypertension Clinical Trial

Official title:

Exercise-induced Pulmonary Hypertension in Patients With Sickle-cell Anemia: an Echocardiographic Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948012
• Other study ID #: HPSC01
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: July 28, 2009
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Pulmonary hypertension (PH) at rest is a risk factor for death in patients with sickle-cell anemia (SCA). Exercise echocardiography (EE) can detect latent PH. We sought to investigate the occurrence of exercise-induced PH in patients with SCA and normal pulmonary pressure (PP) at rest, and its relationship with clinical and echocardiographic variables.Forty-four patients with SCA and normal PP at rest were studied and divided into two groups: exhibiting normal PP after treadmill EE (TRV≤2.7m/s) (G1), and exhibiting exercise-induced PH (TRV>2.7m/s) (G2). TRV cutoff points at rest and during exercise were based on data from healthy control subjects, matched for age, sex, and body surface area. Data obtained from EE were correlated with clinical, echocardiographic and ergometric variables.Exercise-induced PH occurred in 57% of the sample (G2), significantly higher than those of G1. Exercise-induced PH was related to higher levels of creatinine (p<0.05), increased left atrial volume (p<0.05) and right ventricular diastolic area (p<0.05), larger E/Em waves ratio derived from spectral and tissue Doppler (p<0.05), and higher TRV at rest (p<0.005).We concluded that patients with SCA and normal PP at rest may exhibit exercise-induced PH, which was related to renal function, increased cardiac chambers, abnormal indices of diastolic function and baseline TRV levels.

Description:

Pulmonary hypertension (PH) at rest is a risk factor for death in patients with sickle-cell anemia (SCA). Exercise echocardiography (EE) can detect latent PH. We sought to investigate the occurrence of exercise-induced PH in patients with SCA and normal pulmonary pressure (PP) at rest, and its relationship with clinical and echocardiographic variables.Forty-four patients (22 men, mean age 25 y.o.) with SCA and normal PP at rest (tricuspid regurgitant jet flow velocity [TRV] <2.5 m/s) were studied and divided into two groups: exhibiting normal PP after treadmill EE (TRV≤2.7m/s) (G1), and exhibiting exercise-induced PH (TRV>2.7m/s) (G2). TRV cutoff points at rest and during exercise were based on data from healthy control subjects, matched for age, sex, and body surface area. Data obtained from EE were correlated with clinical, echocardiographic and ergometric variables.Exercise-induced PH occurred in 57% of the sample (G2), with mean TRV level of 3.4±0.4 m/s (range 2.8 - 4.5m/s), significantly higher than those of G1 (2.5±0.3 m/s, p<0.001). Exercise-induced PH was related to higher levels of creatinine (p<0.05), increased left atrial volume (p<0.05) and right ventricular diastolic area (p<0.05), larger E/Em waves ratio derived from spectral and tissue Doppler (p<0.05), and higher TRV at rest (p<0.005).We concluded that patients with SCA and normal PP at rest may exhibit exercise-induced PH, which was related to renal function, increased cardiac chambers, abnormal indices of diastolic function and baseline TRV levels. The clinical meaning of these findings requires clarification in future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• patients with Sickle Cell Anemia homozygous to hemoglobin S

• preserved physical capacity

• steady state of the disease

Exclusion Criteria:

• Pulmonary Hypertension at rest

• Recent sickling crisis(<2 months)

• High Blood Pressure

• Atrial fibrillation

• Chronic obstructive pulmonary disease

• Last blood transfusion > 3 months before

• Signs of congestive heart failure or significant valve disease

• Normal global and regional systolic function on echocardiography

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sickle Cell Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise-induced pulmonary hypertension		until one minute after exercise	Yes