Effect of Nutritional Supplementation and Pulmonary Rehabilitation on the Clinical Status of HF and COPD

NCT04432194 | Unknown

• 1 other identifier: C68-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular diseases (CVD) are the leading cause of death in the world and our country. The prevalence of Heart Failure (HF) is 1-2% in the adult population in developed countries, up to 10% among people 70 years of age. Concerning COPD, it is estimated that by 2030 will be the third leading cause of death in the world; the prevalence in Mexico is 18.4%. Also, according to INEGI data, it is the 5th cause of death in people over 65. 50% of patients with COPD die of cardiovascular causes, and they are at higher risk of developing HF, hospital readmissions, and death. Subjects with HF and COPD concomitant have alterations such as; systemic inflammation, loss of muscle mass and strength of both skeletal and respiratory muscles, reduced tolerance to exercise, and lung function, which has an important impact on clinical status, quality of life and prognosis. The objective of nutritional treatment in HF is to reduce heart overload and reduce cardiovascular risk. On the other hand, in COPD, it is to improve lung function. However, this is not enough to maintain the protein reserves of patients due to previously affected factors. Therefore, it is vitally essential to contemplate the supplementation with amino acids that prevent and delay the loss of protein reserves, as well as the delay in clinical status. The β-hydroxy-β-methyl butyrate (HMB) is a metabolite of leucine, with an anticatabolic and anabolic effect. HMB improves the synthesis of proteins, muscle mass, strength, and muscle functionality. Citrulline has been associated with increased muscle mass, VO2, and exercise tolerance. On the other hand, pulmonary rehabilitation (RP) has improved exercise tolerance, mass, and strength of skeletal and respiratory muscles, quality of life, reduction of hospitalizations, and mortality. However, in concomitant HF and COPD, there are no guidelines that specify the type of RP or if there is a synergistic effect with nutritional supplementation and its impact on clinical status.

Conditions

Heart Failure; Copd; Nutritional Supplementation; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Evaluate the effect of nutritional supplementation and pulmonary rehabilitation on the clinical status

  Change from baseline in functional class assessed by NYHA

  Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

• Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over the skeletal muscle mass

  Change from baseline in the skeletal muscle mass assessed by bioelectrical impedance

  Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

• Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over pulmonary function

  Change from baseline in pulmonary function assessed by spirometry test

  Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

• To evaluate the effect of pulmonary rehabilitation and supplementation over muscle function in COPD and HF patients

  Change from baseline in pulmonary function assessed by dinamometry test

  Baseline, 6 weeks after treatment initiation, 12 weeks 6 weeks after treatment initiation

• Evaluated the effect of nutritional supplementation and pulmonary rehabilitation over prognosis in COPD and HF patients

  survival follow-up

  Two years after treatment initiation

Study Arms (4)

Control group

NO INTERVENTION

The subjects in this group will receive the usual care, which includes the non-pharmacology recommendations by the European Society of Cardiologists 2006 (1) and COPD guides for treatment (6), both founded in the sodium and liquids restriction.

Pulmonary Rehabilitation Group

ACTIVE COMPARATOR

Patients in this group will receive pulmonary rehabilitation specified by rehabilitation doctors according to the needs and capacities of each individual, who will attend three times a week for three months.

Dietary Supplement: Nutritional supplementation and Pulmonary Rehabilitation

Pulmonary Rehabilitation Group plus HMB (4g)

EXPERIMENTAL

Patients in this group will receive pulmonary rehabilitation specified by rehabilitation doctors according to the needs and capacities of each individual, who will attend three times a week for three months. Furthermore, they will receive 4g of citrulline supplementation.

Dietary Supplement: Nutritional supplementation and Pulmonary Rehabilitation

Pulmonary Rehabilitation Group plus citrulline (3g)

EXPERIMENTAL

Patients in this group will receive pulmonary rehabilitation specified by the doctor specialized in rehabilitation according to the needs and capacities of each individual, who will attend three times a week for three months. Furthermore, they will receive 4g of citrulline supplementation.

Dietary Supplement: Nutritional supplementation and Pulmonary Rehabilitation

Interventions

Nutritional supplementation and Pulmonary Rehabilitation DIETARY_SUPPLEMENT

Nutritional supplementation (HMB 4g) or Nutritional supplementation (citrulline 3g) with Pulmonary Rehabilitation

Pulmonary Rehabilitation Group; Pulmonary Rehabilitation Group plus HMB (4g); Pulmonary Rehabilitation Group plus citrulline (3g)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that accept and signed the study consent.
• \> 40 years old
• Patients with Heart failure diagnosis confirmed by echocardiographic criteria according to the European Society of Cardiology guidelines (2).
• Heart failure patients in functional class I to III according to NYHA
• Patients with Chronic Obstructive Pulmonary Disease diagnosis according to GOLD guidelines with a post-bronchodilator spirometry VEF1/FVC index \<0.70 (50)

You may not qualify if:

• Patients with recent (\<3 months) exacerbations
• Terminal Chronic Renal Kidney Disease with a creatinine clearance \<30 ml/min/1.73m2
• Patients with a cancer diagnosis
• Patients with limitation to exercise
• Patients enrolled in another study protocol

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Dulce González-Islas

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Leslie Verdeja-Vendrell, M.Sc.

  Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

  PRINCIPAL INVESTIGATOR

• Dulce González-Islas, PhD

  Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

  STUDY DIRECTOR

• Arturo Orea-Tejeda, MD

  Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

  STUDY DIRECTOR

• Martha E Quintero-Martínez, B.Sc

  Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

  STUDY CHAIR

• Ilse C Pérez-García, B.Sc

  Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

  STUDY CHAIR

Central Study Contacts

Dulce González-Islas, PhD

CONTACT

5514364002; gzz.dulce@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 16, 2020
• Study Start: August 30, 2019
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)