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

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

Interventions

DIETARY_SUPPLEMENT

Nutritional supplementation and Pulmonary Rehabilitation

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

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias

  lead OTHER_GOV

Principal Investigators

• Leslie Verdeja-Vendrell, M.Sc. · Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

• Dulce González-Islas, PhD · Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

• Arturo Orea-Tejeda, MD · Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

• Martha E Quintero-Martínez, B.Sc · Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

• Ilse C Pérez-García, B.Sc · Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-30

Primary Completion

2023-07-31

Completion

2023-09-30

Countries

• Mexico

Study Locations